To Study the Effectiveness of Thea chinensis in the Treatment of Primary Dysmenorrhoea: A Prospective Uncontrolled Experimental Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Improvement of the score obtained (pre and post treatment) from WaLIDD score.
研究概览
简要总结
This study is a prospective, uncontrolled, open label, single arm, unicentric, experimental study to assess the effectiveness of Thea chinensis in managing pain of Primary Dysmeorrhoea. This study will evaluate the extend of improvement in pain due to primary Dysmenorrhoea using WaLIDD score as an assessment scale. The primary outcome will be according to the scores obtained (pre and post treatment) from WaLIDD score. The secondary outcome will assess the effectiveness of Thea chinensis in improving pain due to Primary Dysmenorrhoea.
NULL HYPOTHESIS (H0) – Thea chinensis is not effective in managing the pain in cases of primary dysmenorrhoea.
ALTERNATIVE HYPOTHESIS (H1) – Thea chinensis is effective in managing the pain in cases of primary dysmenorrhoea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient giving assent/consent for the study.
- •Any 2 symptoms of the patient corresponding to Thea chinensis: ✓Soreness and tenderness of right ovary/ovaries.
- •âœ“Severe cramp like, uterine bearing down pain.
- •âœ“Pain from beginning to end of period.
- •Diagnostic criteria: Undiagnosed cases will be enrolled after confirming any of 2 following symptoms observed during menstrual period along with lower abdominal/pelvic pain felt at the right and/or left side of the abdomen.
- •âœ“Nausea and/or vomiting.
- •âœ“Diarrhoea/constipation.
- •âœ“Mood disturbances.
排除标准
- •Females who are pregnant or lactating.
- •Females suffering from dysmenorrhoea due to Intrauterine Contraceptive Device (IUCDs).
- •Females suffering from dysmenorrhoea due to any pelvic pathology.
- •Patients with other severe systematic disorders.
- •Patients pursing other treatments and are not willing to leave it.
- •Cases requiring emergency/ surgical interventions.
结局指标
主要结局
Improvement of the score obtained (pre and post treatment) from WaLIDD score.
时间窗: Pre scores will be taken at baseline of treatment and post scores will be assessed at the end of each menstrual cycle till three consecutive cycles.
次要结局
- To assess the effectiveness of Thea chinensis in pain management in cases of Primary Dysmenorrhoea.(12 months)
研究者
Dr Sristi Chakraborty
Dr MPK Homoeopathic Medical College Hospital and Research Centre